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Symbiotic-GI-13: A Study to Learn About Study Medicine Called PF-08634404 as a Single Treatment and Combination Treatment in Adult Participants With a Liver Cancer Called Hepatocellular Carcinoma, That is Too Advanced to be Removed by Surgery and May Have Spread to Other Parts of the Body.

ConditionsCarcinoma, HepatocellularHepatocellular CancerHepatocellular CarcinomaUnresectable Hepatocellular CarcinomaLiver NeoplasmsAdvanced Hepatocellular CarcinomaMetastatic Hepatocellular Carcinoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPfizer

About this trial

The purpose of this study is to learn about the effects of study medicine (PF-08634404) when given alone or with another antibody (ipilimumab) for the treatment of a type of liver cancer called hepatocellular carcinoma (HCC) that is either locally advanced (spread to nearby tissues) or has spread to other parts of the body.

To join the study, participants must meet the following conditions:

* Be 18 years or older. * Have locally advanced or metastatic HCC. * Is not a candidate for complete surgical or loco-regional therapies. * Have not received any whole-body treatment for HCC.

Participants will receive PF-08634404 either alone or in combination with ipilimumab. The medicine will be given through intravenous (IV) infusions, which means it will be administered directly into a vein. All treatments will take place at clinical trial sites, where trained medical staff will monitor participants during and after each visit.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years of age or older at screening.

Locally advanced or metastatic HCC with diagnosis confirmed by histology/cytology or clinically by AASLD criteria (for patients with cirrhosis). Participants without cirrhosis require histological confirmation of diagnosis.

Disease that is not amenable to curative surgical and/or locoregional therapies, or progressive disease after surgical and/or locoregional therapies.

At least 1 measurable (as defined by RECIST 1.1 per investigator) and untreated lesion.

Disqualifiers

Moderate or severe ascites.

History of hepatic encephalopathy.

Participants with known active CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression.

Clinically significant risk of hemorrhage or fistula.

Trial design

Design model

Sequential

Treatments tested in this trial

  • PF-08634404

    Biological/Vaccine

    Solution for infusion

  • Ipilimumab

    Biological/Vaccine

    Solution for infusion

Treatment groups

138 Participants
are divided into 2 treatment groups
Group A: Phase 1bExperimental treatment 2 interventions
Group B: Phase 2Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of Participants With Adverse Events

Adverse Events as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention.

Time frame
Through end of study and up to approximately 24 months
2

Phase 1b: Number of participants with Dose limiting toxicities (DLT)

DLTs are a predefined set of adverse events that are at least possibly related to any or all of the study interventions. The number of participants who experienced DLTs during the DLT observation period.

Time frame
Through 90 days after the last dose of study intervention; Approximately 24 months
3

Phase 2: Confirmed Overall Response Rate (ORR) using RECIST 1.1 as assessed by investigator

ORR is the proportion of participants with a best overall response (BOR) of confirmed CR or confirmed PR per RECIST 1.1 by investigator.

Time frame
Approximately 24 months
4

Phase 2: Recommended dose of PF-08634404 in combination with ipilimumab

The doses of PF-08634404 and ipilimumab selected to be used in combination based on safety, tolerability, pharmacokinetics, and initial anti-tumor efficacy from Phase 2.

Time frame
Approximately 24 months

Secondary outcomes

1

Phase 1b: Confirmed Objective Response Rate (ORR) using RECIST 1.1 as assessed by investigator

ORR is the proportion of participants with a best overall response of confirmed Complete Response (CR) or confirmed Partial Response (PR) per RECIST 1.1 by investigator.

Time frame
Approximately 24 months
2

Duration of Response (DOR) per RECIST 1.1 by investigator

DOR is the time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of first documented disease progression per RECIST 1.1 as assessed by investigator, or death due to any cause, whichever occurs first.

Time frame
Approximately 24 months
3

Progression Free Survival (PFS) per RECIST 1.1 by investigator

PFS is defined as the time from the date of first dose to the date of first documented disease progression per RECIST 1.1 as assessed by investigator, or death due to any cause, whichever occurs first.

Time frame
Approximately 24 months
4

Overall Survival (OS)

OS is defined as the time from the date of first dose to the date of death due to any cause.

Time frame
Approximately 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pfizer

Lead sponsor

Source ClinicalTrials.gov
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